PETROLEUM JELLY COCOA BUTTER- petrolatum cream 
SUHAN AEROSOL

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Health Smart Creamy Petroleum Jelly –Cocoa Butter

Active Ingredient

Petrolatum 30%

Purpose

Skin Protectant

Uses

Warnings

Keep Out of reach of children

If swallowed, get medical help or contact Poison Control Center right away.

Directions 

Apply as needed.

Inactive ingredients

Water,Mineral Oil,Stearic Acid,Glyceryl Monostearate,Cetearyl Alcohol,CM 1000,Fragrance,Triethanolamine,Carbopol 940,Methyl Paraben,
Propyl Paraben,Sodium Lauryl Sulphate,Vitamin E,Cocoa Butter,FD and C Red 40[CI No.16035],FD and C Yellow 5 [CI No .19140].

Product Label

image description

PETROLEUM JELLY COCOA BUTTER 
petrolatum cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73398-113
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MINERAL OIL (UNII: T5L8T28FGP)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CETETH-20 (UNII: I835H2IHHX)  
TROLAMINE (UNII: 9O3K93S3TK)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
COCOA BUTTER (UNII: 512OYT1CRR)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73398-113-01128 g in 1 TUBE; Type 0: Not a Combination Product10/17/2020
Image of Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/17/2020
Labeler - SUHAN AEROSOL (861140760)

Revised: 10/2020
Document Id: b29850d6-0aea-2748-e053-2a95a90a7ff2
Set id: d072239c-c48e-4009-bc1d-201c7d055951
Version: 1
Effective Time: 20201026
 
SUHAN AEROSOL